Blood oxygenator

ABSTRACT

A blood oxygenator is disclosed comprising a housing, a blood inlet, a blood outlet, a spiral volute, a gas inlet, an oxygenator fiber bundle, and a gas outlet. The housing encloses the fiber bundle and provides the structure for the blood flow path and connectors. The fiber bundle comprises gas-exchange membranes which transfer oxygen to the blood and remove carbon dioxide when the blood flows across the membranes. The spiral volute guides the blood to flow through the fiber bundle. A gas flow chamber receives sweep gas containing oxygen and distributes the sweep gas into the fiber membranes, which gas is then exchanged with the blood being oxygenated.

GOVERNMENT LICENSE RIGHTS

This invention was made with government support under Grant NumbersHL082631 and HL118372 awarded by the National Institutes of Health. Thegovernment has certain rights in the invention.

FIELD OF THE INVENTION

This invention relates generally to blood oxygenator devices and methodsof their use, and more particularly to blood oxygenators that provideuniform flow and oxygenation.

BACKGROUND

Hollow fiber membrane blood oxygenators are the current gold standardfor blood oxygenation. These oxygenators typically incorporate one offour blood flow path configurations, as summarized in U.S. Pat. No.5,462,619: (1) longitudinal (axial) flow through an annular bundle (seeU.S. Pat. No. 4,975,247); (2) circumferential flow around an annularbundle (see U.S. Pat. No. 3,794,468); (3) transverse flow across abundle of substantially rectangular cross-section (see U.S. Pat. No.5,188,801); and (4) radially outward flow through an annular bundle (seeU.S. Pat. No. 3,422,008). The specifications of the foregoing areincorporated herein by reference in their entireties.

Although the membrane blood oxygenators based on the above principlesare generally acceptable for cardiopulmonary bypass during open heartsurgeries, they have a number of problems when they are used forrespiratory support over longer durations (e.g., days to weeks). Theyhave a relatively large blood-contacting surface area, a large primevolume, and a large physical size with very limited long-termbiocompatibility and durability. The drawbacks of these oxygenators areassociated with inherent blood fluid dynamics within these oxygenators,including non-uniform blood flow through the fiber membranes, theexistence of laminar boundary flow zones between the blood cells andfiber membranes, and large physical size.

The non-uniform blood flow across the fiber membranes results in hyper-and hypo-perfusion of blood in the flow path. Hyper-perfusion does nothave any additional benefit once blood is oxygen-saturated. In order toassure that all blood cells in the hypo-perfusion region are welloxygenated, longer flow paths are needed, thus resulting in extendedblood contact with the fiber membrane surfaces and a large surface areaof the fiber membranes. When blood flows through fiber membranes, arelatively thick blood boundary layer is developed. The blood boundarylayer that is formed increases the resistance to oxygen diffusion toblood cells that are not directly in contact with the fiber membranesurface. The gas transfer efficiency can be significantly hindered bythe existence of the boundary layer. Therefore, gas exchange membranesurface areas of 2 to 4 m² and a large prime volume are typicallyrequired to provide the needed gas exchange. The non-uniform blood flowcan potentially induce excessive mechanical shear stresses or stasis inthe blood flow path in the oxygenators. These are the major contributingfactors to blood activation and thrombosis formation, resulting inlimited long-term biocompatibility and durability. In addition, thelarge physical size also limits the wearability for ambulatoryrespiratory support.

In recognition of the drawbacks related to the boundary layer zones inthe foregoing patents, methods to decrease the boundary layer effecthave been proposed by increasing the shear rate and/or turbulence of theblood flow path by introduction of secondary flows. The blood isdirected to flow perpendicular or at a substantial angle to the fibermembranes. Examples of this type of design include those described inU.S. Pat. No. 4,639,353 (Takemura) and U.S. Pat. No. 5,263,924(Mathewson), the specifications of which are incorporated herein byreference in their entireties. Takemura describes the arrangement ofbundles of hollow fibers perpendicular to the direction of blood flowvia a series of flow guide structures. Mathewson describes theintegrated centrifugal pump and membrane oxygenator in which the hollowfibers are displaced circumferentially in a ring around an impeller ofthe centrifugal pump. The blood is pumped through the hollow fibers foroxygenation. One drawback of Mathewson's design is that there existpotential stagnant flow zones between the annular fiber bundle and theouter housing wall.

To overcome shortcomings of the prior art in terms of non-uniform bloodflow path and less biocompatibility, a rotating impeller was introducedto generate uniform blood flow through an annular fiber bundle, asdescribed in U.S. Pat. No. 8,496,874. The use of an integrated rotatingimpeller to achieve uniform blood flow may be beneficial. However,integration of the pump with a blood oxygenator into a system canintroduce difficulties for manufacturing and complex flow paths in theintegrated system.

In consideration of the limitations of the foregoing devices, there is aneed for a compact, efficient and non-traumatic blood oxygenator with alow prime volume and a small surface area of gas exchange membranes.

SUMMARY OF THE INVENTION

Disclosed is a unique blood oxygenator that addresses one or more of theshortcomings of the prior art. More particularly, a blood oxygenator isprovided herein having unique blood flow distribution control, resultingin a significant reduction of membrane surface area and priming volume,and reduced trauma when compared with currently known oxygenatortechnologies. Techniques are also provided for a blood oxygenator devicethat provides one or more advantages over currently available bloodoxygenators. In various embodiments, the device provides long-termdurability and reliability, and can be used for, among otherapplications, cardiopulmonary bypass during cardiothoracic surgeries,extracorporeal membrane oxygenation (ECMO) for cardiopulmonary supportor respiratory support in hospitals, and ambulatory ECMO.

In accordance with certain aspects of an embodiment of the invention, ablood oxygenator includes a housing, a blood inlet, a blood outlet, aspiral volute, a gas inlet, an oxygenator fiber bundle, and a gasoutlet. The housing encloses the fiber bundle and provides the structurefor the blood flow path and connectors. The fiber bundle comprisesgas-exchange membranes that transfer oxygen to the blood and removecarbon dioxide when the blood flows across the membranes. The spiralvolute guides the blood to flow through the fiber bundle. The gas flowchamber receives sweep gas containing oxygen and distributes the sweepgas into the fiber membranes.

With regard to further aspects of an embodiment of the invention, a heatexchanger is integrated into the blood oxygenator. The heat exchangeelement is located between an annular space and the fiber bundle.

With regard to still further aspects of an embodiment of the invention,a kit is provided that includes both a blood oxygenator and a bloodpump. The kit may be specifically configured for ambulatorycardiopulmonary and respiratory support.

Still other aspects, features, and advantages of the invention will bereadily apparent from the following detailed description, simply byillustrating a number of particular embodiments and implementations,including the best mode contemplated for carrying out the invention. Theinvention is also capable of other and different embodiments, and itsseveral details can be modified in various obvious respects, all withoutdeparting from the spirit and scope of the invention. Accordingly, thedrawings and description are to be regarded as illustrative in nature,and not as restrictive.

BRIEF DESCRIPTION OF THE FIGURES

The above and other features, aspects, and advantages of the presentinvention are considered in more detail, in relation to the followingdescription of embodiments thereof shown in the accompanying drawings,in which:

FIG. 1 is a perspective view of a blood oxygenator in accordance withcertain aspects of an embodiment of the invention.

FIG. 2 is a cross-sectional view of the blood oxygenator of FIG. 1.

FIG. 3 is a schematic representation of blood flow in the spiral voluteof the blood oxygenator of FIG. 1 at two elevations.

FIG. 4 is a schematic representation of a blood flow path in the spiralvolute and the fiber bundle of the blood oxygenator of FIG. 1.

FIG. 5a is a transparent view showing various elements of the bloodoxygenator of FIG. 1, and FIG. 5b provides the same transparent view andincludes a schematic representation of a blood flow path through theblood oxygenator of FIG. 1.

FIG. 6 is a cross-sectional view of the blood oxygenator of FIG. 1 andfurther comprising a heat exchanger.

FIG. 7 is a perspective view of a blood oxygenator in accordance withfurther aspects of an embodiment of the invention.

FIG. 8 is a side, cross-sectional view of the blood oxygenator of FIG.7.

FIG. 9 is a top, cross-sectional view of the blood oxygenator of FIG. 7.

FIG. 10 is a side, cross-sectional view of the blood oxygenator of FIG.7.

FIG. 11 is a perspective view of the blood oxygenator of FIG. 1detachably attached to a blood pump.

FIG. 12 is a schematic view of the blood oxygenator of FIG. 1 used forambulatory respiratory/cardiopulmonary support.

FIG. 13 is a schematic view of a blood flow path in the fiber bundle inthe blood oxygenator of FIG. 1.

FIG. 14 is a schematic view of a blood flow field in the bloodoxygenator of FIG. 1 (4.0 L/min) created from computational fluiddynamics modeling.

FIG. 15 is a block diagram showing an exemplary setup for the bloodoxygenator of FIG. 1 used for cardiopulmonary bypass surgery.

DETAILED DESCRIPTION

The invention summarized above may be better understood by referring tothe following description, claims, and accompanying drawings. Thisdescription of an embodiment, set out below to enable one to practice animplementation of the invention, is not intended to limit the preferredembodiment, but to serve as a particular example thereof. Those skilledin the art should appreciate that they may readily use the conceptionand specific embodiments disclosed as a basis for modifying or designingother methods and systems for carrying out the same purposes of thepresent invention. Those skilled in the art should also realize thatsuch equivalent assemblies do not depart from the spirit and scope ofthe invention in its broadest form. Likewise, in the followingdescription, for the purposes of explanation, numerous specific detailsare set forth in order to provide a thorough understanding of thepresent invention. It will be apparent, however, to one skilled in theart that the present invention may be practiced without these specificdetails. In other instances, well-known structures and devices are shownin block diagram form in order to avoid unnecessarily obscuring thepresent invention.

A device, system, and method are described herein for a bloodoxygenator. The exterior of a blood oxygenator 100, as shown on FIG. 1,comprises a housing 110 having a top 105 and a bottom 107. The top 105of the housing 110 has a blood outlet 125. In some exemplaryembodiments, the top 105 of the housing includes a gas exhaust port 135and, in some instances, may include a vent port 137 on housing 110(shown on FIG. 2). The bottom 107 of the housing 110 has a blood inlet120 and, in some exemplary embodiments, a gas inlet 130.

The housing 110 encloses the internal elements of blood oxygenator 100,as depicted in FIG. 2, including the oxygenator fiber bundle 150, andprovides the structure for the blood flow path and connectors. The bloodinlet 120 on the bottom 107 of the housing 110 is connected to a spiralvolute 140. As used herein, the phrase “spiral volute” refers to aspiral or helical flow path formed in a cylindrical annulus between theouter, typically cylindrical, surface of the fiber bundle and an innersurface of the housing. The cross-sectional area of the flow path willgenerally be at a maximum at an inlet end of the flow path, and willdecrease toward the outlet end in order to at least partially offset thereduction in flow velocity that would otherwise occur as the blood flowsfrom the flow path into the fiber bundle.

The spiral volute 140 has a first end 141 (shown in the lower elevationof FIG. 3) and a second end 142 (shown in the higher elevation of FIG.3). The blood inlet 120 connects with the spiral volute 140 at the firstend 141. The channel extending between first end 141 and second end 142of the spiral volute 140 defines an internal cavity 143 that decreasesin size from the first end 141 to the second end 142. As shown in FIG.3, as the internal cavity 143 of spiral volute 140 decreases in size, italso moves up in elevation in a spiral formation. In addition to aninternal cavity 143, the spiral volute 140 has an aperture 144 thatconnects the internal cavity 143 to an annular space 145 between aninner wall 113 of housing 110 and an outer surface 147 of an oxygenatorfiber bundle 150 in blood oxygenator 100, as shown in FIGS. 2 and 4. Theaperture 144 allows blood to enter the annular space 145 from theinternal cavity 143.

A uniform blood flow path across the membranes in the fiber bundle 150is achieved by the spiral volute 140. The blood is guided by the bloodinlet 120 into the spiral volute 140 which gradually discharges theblood circumferentially (360 degree) into the annular space 145 betweenthe inner wall 113 of the housing 110 and outer surface 147 of fiberbundle 150. Annular space 145 is generally in the shape of a cylinder,the outer perimeter of which preferably conically tapers inward as theannular space 145 extends away from spiral volute 140. Spiral volute 140extends circumferentially around the interior of housing 110 and has agradually decreasing radius as it extends spirally upwards. The aperture144 of the spiral volute 140 that opens into the cylindrical annularspace 145 is progressively increased and finally merges into the annularspace 145. Further, the aperture 144 of the spiral volute 140 preferablymerges into the annual space about 300° from the first end 141; i.e.,the second end 142 is at a position 300° from the first end 141.

Fiber bundle 150 preferably comprises a cylindrical annulus composed ofthousands of microporous hollow fibers with pore sizes of less than 0.1micron. The membrane fibers are commercially available and range in sizefrom 250 to 400 micron outside diameter with a wall thickness ofapproximately 30 to 50 microns thick. The fiber membranes may or may notinclude an anti-thrombogenic coating containing heparin or a functionalequivalent attached to the outside of each fiber. The porosity (voidratio) of the fiber bundle 150 is determined according to the desiredpressure loss across the fiber bundle, typically ranging from 0.4 to0.7. Alternatively, coated or skinned hollow fibers may be utilized,which permit oxygen and carbon dioxide diffusion through a non-porousskin layer of the outer wall of the fibers. The fibers are typicallycommercially available in a tape configuration whereby individual fibersare arranged to a predetermined configuration (e.g., parallel straightor bias, multi-directional, woven, spaced, etc.) permitting tapewrapping to form a cylindrical or conical-like bundle configuration.Alternatively, the fiber can be wrapped or wound like a spool ofkite-string.

The ends of the fiber bundle 150 are cast potted in a polymer (e.g.,urethane) to form upper potting 154 and lower potting 152. The bundleends are trimmed at upper potting 154 and lower potting 152 to open theinternal passages of the hollow fibers. It is through these inner lumensthat the sweep gas is distributed. The fiber bundle 150 is affixed ontothe housing at the lower potting 152 and upper potting 154. The bloodand gas are structurally separated by the lower potting 152 and theupper potting 154.

As shown in FIG. 2, the fiber bundle 150 is configured to allow blood tomove from the outer surface 147 of fiber bundle 150 through the internalpassages of the hollow fibers into a central lumen 160. The centrallumen 160 is configured to receive blood that travels through fiberbundle. The upper end of lumen 160 communicates with blood outlet 125.Thus, blood travels from the outer surface 147 of the oxygenator fiberbundle 150 through the oxygenator fiber bundle 150, into the centrallumen 160, and out of the housing 110 through the blood outlet 125.Guide structure 162 may optionally be provided within central lumen 160to help channel the blood out of the blood oxygenator 100. The guidestructure 162 extends orthogonally from the bottom 107 of housing 110.

Gas inlet 130 is preferably located in bottom 107 of housing 110. Gasinlet 130 communicates with lower gas flow chamber 132 which allows forthe distribution of the gas into the fiber membranes of the fiber bundle150. An upper gas flow chamber 134 located on the top 105 of the housing110 receives the expelled gas from the fiber membranes and allows forthe gas to exit gas exhaust port 135.

Blood oxygenator 100 preferably also includes a vent port 137, as shownin FIG. 2, positioned within housing 110 at the location at which airbubbles are likely to accumulate. It is important to be able to removegaseous bubbles from the blood oxygenator 100 during use. Bubblestypically result from trapped air failing to adequately de-bubble duringpriming, broken membrane fibers, or excessive negative pressure appliedto the blood drawing gas out of solution.

FIG. 5a provides a transparent view of the blood oxygenator showing theabove components in a fully assembled blood oxygenator 100. FIG. 5bshows the same transparent view, and also shows a schematicrepresentation of a blood flow path through blood oxygenator 100. Moreparticularly, first segment 170 shows the path in which blood entersblood oxygenator 100, from which it travels into the spiral volute alongspiral flow path segment 171. From the start of opening 144 to the endof spiral volute 140, blood likewise flows upward in the direction offlow lines 172 from spiral volute 140 and into annular space 145 in acontinuous, vertical flow path extending circumferentially around fiberbundle 150. As blood flows upward in the direction of flog lines 172, itlikewise flow radially inward in the direction of flow lines 173 andtoward central lumen 160, and then upward through central lumen 160 andout through blood outlet 125.

Blood oxygenator 100 may also optionally provide a heat exchangefunction. As shown in FIG. 6, an optional heat exchange element 180 isprovided in the form of a cylindrical annulus around the fiber bundle150. The heat exchange element 180 is located between the outer surface147 of the fiber bundle 150 and the annular space 145. The heat exchangeelement may be comprised of capillaries formed together to construct acylindrical annulus, and potted together with the fiber bundle. The heatexchange element capillaries can either be made of biocompatible metalsor polymers. After being potted, the lumen of the capillaries can beopened using the same approach as for the hollow fibers of fiber bundle150. A separate flow path through the heat exchange element capillariesis provided. In this configuration, enclosed chambers are disposed inthe housing above the upper potting 154 and below the lower potting 152.A first chamber 134 is provided above the upper potting 154 for thesweep gas and is in fluid communication with exit gas exhaust port 135,while a second chamber 534 is provided above the upper potting 154 andis in fluid communication with exhaust port 535 for the heat transfermedium. Likewise, a first chamber 132 is again provided below the lowerpotting 152 for the sweep gas and is in fluid communication with gasinlet 130 (not shown in FIG. 5), while a second chamber 532 is providedbelow lower potting 152 and is in fluid communication with an inlet 530for supply of the heat transfer medium. When the heat transfer mediumand sweep gas flow through the capillaries of the heat exchanger and thefiber membranes, respectively, the blood is heated and controlled fortemperature, the oxygen is transferred to the blood, and carbon dioxideis removed from the blood while the blood radially flows through theheat exchange element 180 and the fiber bundle 150. Other means forheating the blood may also be used without departing from the spirit orscope of the invention. For example, a portion of the oxygen fibers maybe substituted with fibers that enable heat exchange. Such aconfiguration would also utilize hollow tube(s), the inside of whichcould flow temperature controlled water or other fluid to affect bloodtemperature change and/or maintenance.

As shown in FIG. 7, blood may alternatively enter into housing 110through a flow path that is adjacent to the mid-section of fiber bundle150, and need not enter housing 110 through the bottom of housing 110.More particularly, and with reference to FIGS. 7 through 10, housing 110may include a top housing section 602, a bottom housing section 604, anda mid-housing section 610. While each of such housing sections aregenerally cylindrical in form, top housing section 602 and bottomhousing section 604 preferably have the same diameter, and moreover areconfigured alike to the corresponding portions of housing 110 shown inFIG. 2, while mid-housing section 610 has a wider diameter so as toincorporate spiral volute 640. Bottom housing section 604 includes gasinlet 130 configured as described above, with first chamber 132 incommunication with gas inlet 130 to receive the sweep gas.

Likewise, fiber bundle 150 is provided inside of housing 110, and ispositioned so that lower potting section 152 of fiber bundle 150 ispositioned within bottom housing section 604, upper potting section 154of fiber bundle 150 is positioned within top housing section 602, andthe central gas exchange portion of fiber bundle 150 is positionedwithin mid-housing section 610. Top housing section 602 also includesgas exhaust port 135 configured as described above, and blood outlet 125configured as described above and in communication with an internal,central lumen 160 which may optionally include a guide structure 162,again all configured as described above.

With particular reference to FIGS. 7 and 8, the spiral volute 640 ispositioned in the space between the outer surface 147 of fiber bundle150 and the inner wall 113 of housing 110. As shown in FIG. 8, circularblood inlet 120 is positioned in the middle of mid-housing section 610.At the inner end 121 of blood inlet 120, the blood flow bath begins tovertically widen, expanding into the full vertical height of spiralvolute 140 (generally equal in dimension to the radially absorptiveportion of fiber bundle 150) through a transitional area 620. Whiletransitional area 620 vertically expands the blood flow path, itlikewise progressively narrows that flow path by narrowing the gapbetween the outer surface 147 of the fiber bundle 150 and the inner wall113 of housing 110, as best shown in the top-down, sectional view ofFIG. 9.

With continued reference to FIG. 9, at the end of spiral volute 640(i.e., after 360° from the interior end 122 of transitional area 620),the inner wall 113 of housing 110 is nearly contiguous with the outersurface 147 of fiber bundle 150. Thus, blood entering through bloodinlet 120 and passing therefrom into transitional area 620 diverges asit passes through transitional area 620, and from transitional area 620enters into the spiral volute 640 to begin circulation around fiberbundle 150. Moreover, as blood circulates through spiral volute 640around fiber bundle 150, a portion of the blood volume that is incontact with the fiber bundle 150 enters radially into the porous fiberbundle while the portion of the blood volume that is closer to the innerwall 113 of housing 110 continues its circumferential flow around thefiber bundle 150, until it eventually enters fiber bundle 150. In thisconfiguration, the uniform blood flow across fiber bundle 150 isachieved 360° around fiber bundle 150 and from the bottom to the top ofthe fiber bundle 150.

As shown in FIG. 11, the blood oxygenator 100 may be connected to ablood pump 230. Pump 230 is connected to the blood inlet of bloodoxygenator 100, such as through a quick connector 190 of standardconfiguration. Furthermore, pump 230 and blood oxygenator 100 may beprovided together as a kit. It is contemplated that the kit may comprisethe various elements required for the blood oxygenator 100 to function.Such kits may be particularly useful for ambulatory cardiopulmonary andrespiratory support. In certain configurations, blood pump 230 and bloodoxygenator 100 can both be contained within housing 110 in a singleunit.

Blood oxygenator 100 may likewise be connected to a portable oxygen tankand worn on the user, as depicted in FIG. 12(a). In FIG. 12(a), straps708 of a portable oxygen tank are shown, in which case the portableoxygen tank may be positioned on the user's back. The oxygen tank isconnected to blood oxygenator 100. Likewise, blood oxygenator 100 andthe oxygen tank may be placed inside a cart or bag 740 that the user canmanage as shown in FIG. 12(b). As shown particularly in FIG. 12(a), anoxygen concentrator 730 may be positioned to receive oxygen from theportable oxygen tank and to deliver it to blood oxygenator 100. Theoxygen concentrator 730 converts air into high oxygen concentration(>90%) gas. A portable drive console may be provided that can optionallyenclose each of the oxygen concentrator 730, a battery power pack, andelectronics for the blood pump, flow sensors and blood gas sensors. Kitsmay be provided that comprise two or more of the components describedabove.

Blood oxygenator 100 may also optionally include arterial and venoussample ports (not shown) permitting blood samples to be collected by asyringe, such as (by way of non-limiting example) traditional stopcocksor obturator-type sample ports. The sampling ports should provide forthe extraction of whole blood from sites before and after the fiberbundle 150 to enable the user to adjust blood flow rates, gas transferrates and pH for control of oxygen concentration.

The design of the blood oxygenator 100 as configured herein optimizesblood flow. Many of the elements of blood oxygenator 100 that transportpatient blood are generally cylindrical or round to promote even flowand reduce turbulence and stagnation. Blood enters the blood inlet 120with tangential blood velocity relative to the outer surface of thefiber bundle 150. A portion of the blood volume continues to flow in thevolute with mainly circumferential velocity, and a portion of the bloodvolume gradually leaves the volute to enter the annular space 145 withspiral-circumferential velocity. This blood flow discharge mechanismprovides a circumferential flow field around the fiber bundle 150 withequal pressure distribution prior to entering the fiber bundle by thespiral volute 140. With this equal pressure distribution, blood radiallyflows inward through the fiber membranes in the fiber bundle 150.Because the length from the outer surface and inner surface of the fiberbundle 150 is the same 360 degrees around and from the lower potting 152to the upper potting 154, a uniform blood flow is achieved with minimalpressure loss in the fiber membranes. The existence of thecircumferential velocity of the blood around the outer surface of thefiber bundle 150 induces a mixing effect at the initial radial flowthrough the bundle to reduce the boundary layer of the blood and placered blood cells in closer contact to alleviate CO₂ and diffuse O₂.Exemplary blood flow paths resulting from the configuration of bloodoxygenator 100 as described herein are illustrated in FIGS. 13 and 14.

The design of blood oxygenator 100 also allows for optimized gas flowand diffusion. The lower gas flow chamber 132 receives the sweep gasfrom the gas inlet 130 and distributes oxygen gas to the open lumenfibers imbedded in potting material (and particularly lower potting 152)of the fiber bundle 150. The oxygen flows through the lumen and diffusesacross the outer wall of the individual fiber membranes into the blood,thus allowing blood oxygenation to take place. In parallel, the carbondioxide from the blood diffuses into the lumen of the fiber membranesand is removed from the blood. The sweep gas flows through the fiber andexits the blood oxygenator 100 through the gas exhaust port 135 in theupper flow chamber 134 of the housing 110 above the upper potting 154.The lower gas flow chamber 132 ensures that a low pressure and uniformsweep gas is established in all the fibers simultaneously. The gas inlet130 receives the sweep gas to deliver the sweep gas to the interior ofblood oxygenator 100.

The blood inflow and outflow connectors may be sized as required fordesired blood flow rates and pressures. Typically, such devices arefitted with ¼″ or ⅜″ barbed fittings receiving standard extracorporealtubing, although other sizes may be used.

FIG. 15 provides a block diagram depicting one exemplary setup using theblood oxygenator 100. Blood is taken from a patient through drainagecannula 210 and enters into reservoir 220. Blood pump 230 forces bloodfrom the reservoir 220, into blood oxygenator 100 (configured asdescribed above), and back to the patient through return cannula 215. Agas/oxygen source 240 communicates with the blood oxygenator 100 toprovide oxygen. A water-heat circulator 250 preferably also communicateswith blood oxygenator 100 in those configurations that employ a heatexchange function. Sensors may be used to retrieve information about theblood, such as blood gas concentration sensors 261, blood flow ratesensors 262, and blood temperature sensors 263.

Embodiments may include microporous membranes to filter blood componentsas utilized in blood dialysis. Further, embodiments may include a filter(e.g., depth filter, reticulated foam, microporous filtration,filtration mediums, etc.) to capture particulate matter as a fluid isdriven through the filter.

The blood oxygenator 100 disclosed herein has improved manufacturabilityover other similar designs of blood oxygenators. It includes fewercomponents than other blood oxygenating devices. Further, the joints andbonding area may be easily accessed, which makes the blood oxygenator100 easier, cheaper and more reliable to manufacture.

In the foregoing specification, the invention has been described withreference to specific embodiments thereof. It will, however, be evidentthat various modifications and changes may be made thereto withoutdeparting from the broader spirit and scope of the invention. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than a restrictive sense. Throughout thisspecification and the claims, unless the context requires otherwise, theword “comprise” and its variations, such as “comprises” and“comprising,” will be understood to imply the inclusion of a stateditem, element or step or group of items, elements or steps but not theexclusion of any other item, element or step or group of items, elementsor steps. Furthermore, the indefinite article “a” or “an” is meant toindicate one or more of the item, element or step modified by thearticle.

What is claimed is:
 1. A blood oxygenator, comprising: a housingcomprising a blood inlet and a blood outlet, a spiral volute in fluidcommunication with said blood inlet, and an oxygenator fiber bundle;said spiral volute defining an internal cavity extending around an outerperimeter of said fiber bundle, said internal cavity decreasing in widthfrom a first end of said spiral volute to a second end of said spiralvolute and being configured to uniformly distribute blood to an outersurface of said fiber bundle; and a blood pump connected to said bloodinlet.
 2. The blood oxygenator of claim 1, wherein said second end islocated 300° from said first end.
 3. The blood oxygenator of claim 1,said housing further comprising a gas inlet.
 4. The blood oxygenator ofclaim 3, wherein said gas inlet is in fluid communication with a lowergas chamber located below said fiber bundle in said housing.
 5. Theblood oxygenator of claim 4, wherein said lower gas chamber isconfigured to deliver gas into individual lumens in said fiber bundle.6. The blood oxygenator of claim 1, wherein the fiber bundle furthercomprises an upper potting and a lower potting.
 7. The blood oxygenatorof claim 1, wherein said blood pump is inside said housing.
 8. The bloodoxygenator of claim 1, further comprising a heat exchange elementbetween said outer surface of said oxygenator fiber bundle and anannular space located between an inner wall of said housing and an outersurface of said oxygenator fiber bundle.
 9. The blood oxygenator ofclaim 1, further comprising a guide structure extending orthogonallyfrom a bottom of the housing and through a central lumen within saidoxygenator fiber bundle.
 10. The blood oxygenator of claim 1, furthercomprising a central lumen in said oxygenator fiber bundle configured toreceive blood that has travelled from said outer surface of theoxygenator fiber bundle through the oxygenator fiber bundle, and todirect blood to said blood outlet.
 11. The blood oxygenator of claim 1,said spiral volute further comprising an aperture configured to allowblood to enter an annular space located between an inner wall of saidhousing and an outer surface of said oxygenator fiber bundle from saidinternal cavity.
 12. The blood oxygenator of claim 11, wherein saidaperture of the spiral volute is progressively increased and finallymerged into said annular space.
 13. The blood oxygenator of claim 1,further comprising a blood flow transitional area vertically wideningfrom a first height dimension at an internal end of said blood inlet toa second height dimension equal to a height dimension of a radiallyabsorptive portion of said oxygenator fiber bundle.
 14. A method foroxygenating blood through a blood oxygenator, comprising: receiving astream of blood through an inlet and directing said stream into a spiralvolute defining an internal cavity, said internal cavity decreasing inwidth from a first end of said spiral volute to a second end of saidspiral volute, and being configured to uniformly distribute blood to anouter surface of an oxygenator fiber bundle; wherein the blood movesfrom said spiral volute through the oxygenator fiber bundle and into acentral lumen and is oxygenated as it moves through the oxygenator fiberbundle and into the central lumen; and discharging the blood through ablood outlet connected to said central lumen.
 15. The method of claim14, wherein the blood travels through the oxygenator fiber bundle in asubstantially uniform blood flow distribution.
 16. A blood oxygenator,comprising: a housing comprising a blood inlet and a blood outlet, aspiral volute in fluid communication with said blood inlet, and anoxygenator fiber bundle; said spiral volute defining an internal cavityextending around an outer perimeter of said fiber bundle, said internalcavity decreasing in width from a first end of said spiral volute to asecond end of said spiral volute and being configured to uniformlydistribute blood to an outer surface of said fiber bundle; and a heatexchange element between said outer surface of said oxygenator fiberbundle and an annular space located between an inner wall of saidhousing and an outer surface of said oxygenator fiber bundle.
 17. Theblood oxygenator of claim 16, wherein said second end is located 300°from said first end.
 18. The blood oxygenator of claim 16, said housingfurther comprising a gas inlet.
 19. The blood oxygenator of claim 18,wherein said gas inlet is in fluid communication with a lower gaschamber located below said fiber bundle in said housing.
 20. The bloodoxygenator of claim 19, wherein said lower gas chamber is configured todeliver gas into individual lumens in said fiber bundle.
 21. The bloodoxygenator of claim 16, wherein the fiber bundle further comprises anupper potting and a lower potting.
 22. The blood oxygenator of claim 16,further comprising a blood pump connected to said blood inlet.
 23. Theblood oxygenator of claim 22, wherein said blood pump is inside saidhousing.
 24. The blood oxygenator of claim 16, further comprising aguide structure extending orthogonally from a bottom of the housing andthrough a central lumen within said oxygenator fiber bundle.
 25. Theblood oxygenator of claim 16, further comprising a central lumen in saidoxygenator fiber bundle configured to receive blood that has travelledfrom said outer surface of the oxygenator fiber bundle through theoxygenator fiber bundle, and to direct blood to said blood outlet. 26.The blood oxygenator of claim 16, said spiral volute further comprisingan aperture configured to allow blood to enter an annular space locatedbetween an inner wall of said housing and an outer surface of saidoxygenator fiber bundle from said internal cavity.
 27. The bloodoxygenator of claim 26, wherein said aperture of the spiral volute isprogressively increased and finally merged into said annular space. 28.The blood oxygenator of claim 16, further comprising a blood flowtransitional area vertically widening from a first height dimension atan internal end of said blood inlet to a second height dimension equalto a height dimension of a radially absorptive portion of saidoxygenator fiber bundle.
 29. A blood oxygenator, comprising: a housingcomprising a blood inlet and a blood outlet, a spiral volute in fluidcommunication with said blood inlet, and an oxygenator fiber bundle;said spiral volute defining an internal cavity extending around an outerperimeter of said fiber bundle, said internal cavity decreasing in widthfrom a first end of said spiral volute to a second end of said spiralvolute and being configured to uniformly distribute blood to an outersurface of said fiber bundle; wherein said spiral volute furthercomprises an aperture configured to allow blood to enter an annularspace located between an inner wall of said housing and an outer surfaceof said oxygenator fiber bundle from said internal cavity.
 30. The bloodoxygenator of claim 29, wherein said second end is located 300° fromsaid first end.
 31. The blood oxygenator of claim 29, said housingfurther comprising a gas inlet.
 32. The blood oxygenator of claim 31,wherein said gas inlet is in fluid communication with a lower gaschamber located below said fiber bundle in said housing.
 33. The bloodoxygenator of claim 32, wherein said lower gas chamber is configured todeliver gas into individual lumens in said fiber bundle.
 34. The bloodoxygenator of claim 29, wherein the fiber bundle further comprises anupper potting and a lower potting.
 35. The blood oxygenator of claim 29,further comprising a blood pump connected to said blood inlet.
 36. Theblood oxygenator of claim 35, wherein said blood pump is inside saidhousing.
 37. The blood oxygenator of claim 29, further comprising a heatexchange element between said outer surface of said oxygenator fiberbundle and an annular space located between an inner wall of saidhousing and an outer surface of said oxygenator fiber bundle.
 38. Theblood oxygenator of claim 29, further comprising a guide structureextending orthogonally from a bottom of the housing and through acentral lumen within said oxygenator fiber bundle.
 39. The bloodoxygenator of claim 29, further comprising a central lumen in saidoxygenator fiber bundle configured to receive blood that has travelledfrom said outer surface of the oxygenator fiber bundle through theoxygenator fiber bundle, and to direct blood to said blood outlet. 40.The blood oxygenator of claim 29, wherein said aperture of the spiralvolute is progressively increased and finally merged into said annularspace.
 41. The blood oxygenator of claim 29, further comprising a bloodflow transitional area vertically widening from a first height dimensionat an internal end of said blood inlet to a second height dimensionequal to a height dimension of a radially absorptive portion of saidoxygenator fiber bundle.